Premature Ovarian InsufficiencyPhase 1CBT210-POI_P1NCT06578039
Phase 1 Clinical Trial of CordSTEM-ST
A Phase 1 study testing umbilical cord-derived mesenchymal stem cell in people with Premature Ovarian Insufficiency, run by CHABiotech CO., Ltd at 1 site in South Korea.
Trial summary
This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects. Read more about this study
- Who is it for?
- Ages 25 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- umbilical cord-derived mesenchymal stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2024to 28 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged ≥ 25 years and < 40 years
- Individuals diagnosed with premature ovarian insufficiency: Individuals who have a follicle stimulating hormone (FSH) level of 40 IU/L or higher in the results of two tests conducted at least 4 weeks apart and are amenorrheic for at least 4 months
- Individuals who voluntarily decide to participate and provide written consent
Who cannot join
- Individuals diagnosed with primary amenorrhea*
- No secondary sex characteristics by age 13, Absence of menarche for 5 years after initial breast development, or Absence of menstruation by age 15
- Individuals diagnosed with polycystic ovary syndrome
- Individuals with any other conditions that may affect the result of this study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 463-712
About this study
Official title: Single-dose, Phase 1 Clinical Trial to Evaluate the Safety, and Tolerability of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cell Therapy in Patients With Premature Ovarian Insufficiency
This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects.
Read the detailed description
3 or 6 subjects will be enrolled sequentially by applying the "traditional 3+3 design" to evaluate the dose limiting toxicities (DLTs) for 28 days from the first administration date of the investigational product according to the protocol. A DLT is defined as the occurrence of a grade 3 or higher adverse drug reaction (ADR) according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
First three subjects will be enrolled in Study Group 1 (low dose group) to be evaluated for DLTs up to 28 days after IP administration. If none of three subjects develope DLT, three subjects for Study Group 2 (high dose group) will be recruited. If one out of three subjects in Study Group 1 develop DLT, additional three subjects in Study Group 1 will be enrolled to be evaluated for DLT. If two or more subjects develop DLT in initial three subjects, the study will be terminated.
This study will be followed up by a long-term follow-up study under the separate protocol.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- umbilical cord-derived mesenchymal stem cell
- Keywords
- Stem cell therapy, allogeneic stem cell, umbilical cord derived mesenchymal stem cell
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord-derived mesenchymal stem cellBiological
Also called CordSTEM-ST
allogeneic umbilical cord-derived mesenchymal stem cell
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 (Low dose CordSTEM-ST) | Experimental | Low dose CordSTEM-ST, 1 (single) administration Receives: Biological: umbilical cord-derived mesenchymal stem cell |
| Study Group 2 (High dose CordSTEM-ST) | Experimental | High dose CordSTM-ST, 1 (single) administration Receives: Biological: umbilical cord-derived mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of adverse event cases reported
Measured: up to 6 months after the IP administration
Abnormality cases in lab test results
Number of clinically significant abnormalities found in lab test results.
Measured: up to 6 months after the IP administration
Abnormality cases physical exam results
Number of clinically significant abnormalities found in physical exam results
Measured: up to 6 months after the IP administration
Abnormality cases in vital signs
Number of clinically significant abnormalities found in vital signs
Measured: up to 6 months after the IP administration
Secondary outcomes (7)
Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level
blood Follicle Stimulating Hormone (FSH) level measured in mIU/ml
Measured: up to 6 months after the IP administration
Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level
blood Anti-Mullerian Hormone (AMH) level measured in ng/ml
Measured: up to 6 months after the IP administration
Percent change from baseline blood Estradiaol (E2) level
blood Estradiaol (E2) level measured in pg/ml
Measured: up to 6 months after the IP administration
Percent change from baseline in number of mature follicles
number of mature follicles measured in number of follicles
Measured: up to 6 months after the IP administration
Percent change from baseline in number of antral follicles
number of antral follicles measured in number of follicles
Measured: up to 6 months after the IP administration
Percent change from baseline in endometrial thickness
endometrial thickness measured in cm
Measured: up to 6 months after the IP administration
Status of menstruation resumption
Collected by patient interview
Measured: up to 6 months after the IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 Aug 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHABiotech CO., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578039
- Sponsor's protocol ID
- CBT210-POI_P1
- Acronym
- CBT210-POI_P1
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Phase 1 Clinical Trial to Evaluate the Safety, and Tolerability of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cell Therapy in Patients With Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT06578039
- Acronym / sponsor ID
- CBT210-POI_P1 / CBT210-POI_P1
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- Stem cell therapy, allogeneic stem cell, umbilical cord derived mesenchymal stem cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CHABiotech CO., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects.
Detailed description
3 or 6 subjects will be enrolled sequentially by applying the "traditional 3+3 design" to evaluate the dose limiting toxicities (DLTs) for 28 days from the first administration date of the investigational product according to the protocol. A DLT is defined as the occurrence of a grade 3 or higher adverse drug reaction (ADR) according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
First three subjects will be enrolled in Study Group 1 (low dose group) to be evaluated for DLTs up to 28 days after IP administration. If none of three subjects develope DLT, three subjects for Study Group 2 (high dose group) will be recruited. If one out of three subjects in Study Group 1 develop DLT, additional three subjects in Study Group 1 will be enrolled to be evaluated for DLT. If two or more subjects develop DLT in initial three subjects, the study will be terminated.
This study will be followed up by a long-term follow-up study under the separate protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 (Low dose CordSTEM-ST) | Experimental | Biological: umbilical cord-derived mesenchymal stem cellLow dose CordSTEM-ST, 1 (single) administration |
| Study Group 2 (High dose CordSTEM-ST) | Experimental | Biological: umbilical cord-derived mesenchymal stem cellHigh dose CordSTM-ST, 1 (single) administration |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females aged ≥ 25 years and < 40 years
- Individuals diagnosed with premature ovarian insufficiency: Individuals who have a follicle stimulating hormone (FSH) level of 40 IU/L or higher in the results of two tests conducted at least 4 weeks apart and are amenorrheic for at least 4 months
- Individuals who voluntarily decide to participate and provide written consent
Key exclusion criteria (4 listed)
- Individuals diagnosed with primary amenorrhea*
- Individuals diagnosed with polycystic ovary syndrome
- Individuals with any other conditions that may affect the result of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| umbilical cord-derived mesenchymal stem cellAlso: CordSTEM-STallogeneic umbilical cord-derived mesenchymal stem cell | Biological | Study Group 1 (Low dose CordSTEM-ST), Study Group 2 (High dose CordSTEM-ST) |
Primary outcome
Number of adverse events
Time frame: up to 6 months after the IP administration
Number of adverse event cases reported
Abnormality cases in lab test results
Time frame: up to 6 months after the IP administration
Number of clinically significant abnormalities found in lab test results.
Abnormality cases physical exam results
Time frame: up to 6 months after the IP administration
Number of clinically significant abnormalities found in physical exam results
Abnormality cases in vital signs
Time frame: up to 6 months after the IP administration
Number of clinically significant abnormalities found in vital signs
7 secondary outcomes
Percent change from baseline in blood Follicle Stimulating Hormone (FSH) level
Time frame: up to 6 months after the IP administration
Percent change from baseline in blood Anti-Mullerian Hormone (AMH) level
Time frame: up to 6 months after the IP administration
Percent change from baseline blood Estradiaol (E2) level
Time frame: up to 6 months after the IP administration
Percent change from baseline in number of mature follicles
Time frame: up to 6 months after the IP administration
Percent change from baseline in number of antral follicles
Time frame: up to 6 months after the IP administration
Percent change from baseline in endometrial thickness
Time frame: up to 6 months after the IP administration
Status of menstruation resumption
Time frame: up to 6 months after the IP administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing umbilical cord-derived mesenchymal stem cell in people with Premature Ovarian Insufficiency, run by CHABiotech CO., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: up to 6 months after the IP administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.